Kessel Medical is ISO 13485:2016 Certified

Kessel Medical has been certified to the ISO 13485 standard for the procurement, importation, warehousing and distribution of medical devices.

ISO 13485:2016 is the International Standard for Quality Management Systems for Medical Devices. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognised as an aid in supporting compliance with the Medical Device Directive.

We are very proud to be celebrating this achievement!